Data / Medical devices / Belgium / Fujirebio Europe N.V.
Fujirebio Europe N.V.: FDA-registered device maker in GHENT Oost-Vlaanderen, Belgium, 1 510(k) clearance and 1 PMA approval
Fujirebio Europe N.V. is registered with the FDA (registration 9615837) in GHENT Oost-Vlaanderen, Belgium. It lists 5 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615837
- FEI number
- 3002608770
- Address
- Technologiepark 6, GHENT Oost-Vlaanderen, Belgium, B-9052
- Owner or operator
- Fujirebio Diagnostics, Inc. (10022860)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 19, 2016
- Registered through
- 2026
- Brand names listed
- ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA) - Siemens, ADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens, ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens, ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens, ARCHITECT CYFRA 21-1 Controls, ARCHITECT CYFRA 21-1 Controls (China), ARCHITECT CYFRA 21-1 Controls (ROW), ARCHITECT Methotrexate Extended Range Controls (China) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Assay, Genotyping, Hepatitis C Virus | OBF | 2 | Manufacturer | accessdata.fda.gov |
| Cytokeratin Fragments 21-1 Eia Kit | OVK | 2 | Contract manufacturer | accessdata.fda.gov |
| Immunoassay Blood Test For Amyloid Pathology Assessment | SET | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2025 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 14, 2017 | P160016 | VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) | OBF | 5 | September 23, 2020 | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay Blood Test For Amyloid Pathology Assessment
- All makers of Cytokeratin Fragments 21-1 Eia Kit
- All makers of Assay, Genotyping, Hepatitis C Virus
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated May 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.